Esketamine Versus Propofol for Rapid Sequence Intubation in Critically Ill Patients: A Prospective, Randomized, Open-Label, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Lowest Mean Arterial Pressure Within 10 Minutes After Induction
研究概览
简要总结
The goal of this clinical trial is to compare how esketamine and propofol affect blood pressure in critically ill adults who need a breathing tube in an intensive care unit (ICU). Placing a breathing tube into the windpipe is called tracheal intubation. Medicines are given to make patients unconscious and relax their muscles so the tube can be placed quickly. This procedure is called rapid sequence intubation. Blood pressure can fall during this process.
The main question is whether esketamine leads to a higher minimum blood pressure than propofol during the first 10 minutes after the study medicine is given. Researchers will measure mean arterial pressure, which is the average pressure in the arteries during one heartbeat. The study will also compare the need for medicines to support blood pressure, complications around tube placement, survival, time on a breathing machine, and length of ICU stay.
The study will enroll 130 adults aged 18 years or older at one hospital in China. Participants will be assigned by chance, like flipping a coin, to receive either esketamine or propofol through a vein before tube placement. Each participant will have an equal chance of receiving either medicine. The treating team will know which medicine is given. Both groups will receive a muscle relaxant and follow the same standard procedures for tube placement and blood pressure support.
The care team will closely monitor blood pressure, heart rate, and blood oxygen levels before and after tube placement. Researchers will record side effects, including high blood pressure, a fast heart rate, and confusion after the procedure. Participants will continue to receive usual ICU care and will be followed until hospital discharge or death, for up to 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Critically ill patient receiving care in the participating intensive care unit (ICU) and requiring emergency tracheal intubation using a rapid sequence intubation technique, as determined by the treating clinician.
- •Written informed consent provided by the participant or a legally authorized representative. Deferred consent is permitted under the protocol when the participant cannot provide consent because of critical illness, a legally authorized representative cannot be reached in time, and delaying intubation could cause irreversible harm. In these circumstances, written informed consent must be obtained as soon as possible and no later than 72 hours after intubation.
排除标准
- •Emergency tracheal intubation during cardiac arrest.
- •Known or suspected elevated intracranial pressure.
- •Severe bradycardia, defined as a heart rate below 50 beats per minute.
- •Known allergy to esketamine or propofol.
- •Pregnancy or breastfeeding.
- •Untreated or inadequately treated hyperthyroidism.
- •Severe chronic liver disease, classified as Child-Pugh class C.
- •Alcohol or opioid dependence.
- •Psychiatric illness or severe cognitive impairment.
研究组 & 干预措施
Propofol Group
干预措施: Propofol (Drug)
Esketamine Group
干预措施: Esketamine (Drug)
结局指标
主要结局
Lowest Mean Arterial Pressure Within 10 Minutes After Induction
时间窗: From administration of the study induction drug through 10 minutes after administration.
The lowest mean arterial pressure (MAP), measured in mmHg, recorded during the first 10 minutes after administration of the study induction drug. Blood pressure will be monitored using an arterial catheter, and MAP values will be recorded every 1-2 minutes.
次要结局
- Average Mean Arterial Pressure During the First Hour After Induction(From administration of the study induction drug through 60 minutes after administration.)
- Percentage of Participants With Cardiovascular Collapse(From administration of the study induction drug through 2 minutes after tracheal intubation.)
- Percentage of Participants With Severe Hypotension(From administration of the study induction drug through 60 minutes after administration.)
- Percentage of Participants With Severe Hypoxemia(From administration of the study induction drug through 60 minutes after administration.)
- Percentage of Participants With Cardiac Arrest(From administration of the study induction drug through 60 minutes after administration.)
- Time to Successful Tracheal Intubation(From the start of study induction drug administration until confirmation of successful tracheal intubation during the intubation procedure.)
- All-Cause Mortality Within 7 Days(From randomization through Day 7.)
- All-Cause Mortality Within 28 Days(From randomization through Day 28.)
- All-Cause Mortality During Hospitalization(From randomization until hospital discharge or death, whichever occurs first, up to 60 days.)
- Cumulative Vasopressor Dose During the First 24 Hours(From randomization through 24 hours after randomization.)
- Duration of Invasive Mechanical Ventilation(From tracheal intubation until first successful liberation from invasive mechanical ventilation, with observation ending at hospital discharge or death and a maximum follow-up of 60 days.)
研究者
Jiancheng Zhang
Jiancheng Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology